The Pulse of Natural Health Newsletter

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Dangerous Lawsuit Threatens the Few Supplement Health Claims Currently Allowed

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A new lawsuit filed by a “consumer watchdog” group says most Americans are not vitamin deficient and don’t benefit from supplements. Huh?

Earlier this month we told you about international pharmaceutical company Bayer AG’s battle with the Federal Trade Commission over whether its marketing statements about its probiotic colon supplement are unsubstantiated disease claims (not allowed) or structure/function claims (allowed). This week, the Center for Science in the Public Interest (CSPI) filed a class action lawsuit in federal court against Bayer because of its “false claims on ads and labels” for its One A Day Vitamins. The group is asking for an injunction against specific marketing statements, and seeking refunds to consumers.

According to CSPI, the multivitamin’s claims—“supports heart health,” “supports immunity,” and “supports physical energy”—amount to “illegal disease prevention claims designed to deceive consumers.” Bayer, on the other hand, contends these are structure/function claims. The landmark Dietary Supplement Health and Education Act of 1994 created special protections for structure/function claims—and they do not require preapproval by the FDA.

Structure/function claims are statements that describe the role of a nutrient or dietary ingredient as it affects normal structure or function in humans—for example, “calcium builds strong bones” or “vitamin D boosts immune system function.”

S/F claims are an important way dietary supplement makers can inform the public about the health benefits of their product, since they are prevented from making health claims. But it all comes back to our famous “Catch-22”: that no supplement company will spend the exorbitant sums needed to run clinical trials (which is the only way health claims can legally be made) if the product can’t be patented and turned into a huge money-maker. Because health claims are impossible for such supplements, structure/function claims are even more critical—while they don’t provide specific information, they at least guide the consumer toward optimal health in a specific area.

CSPI claims—speciously, in our estimation—that “scientific studies prove that supplementation with [vitamins A, C, and E, as well as selenium, iron, beta carotene, and zinc]have no effect on adults’ immunity in developed countries like the United States.” In fact, many developed countries (like the United States) have an overfed but undernourished population. We document the obesity/malnutrition issue thoroughly in our comments to the FDA regarding their proposed nutrition fact panel changes.

CSPI’s anti-supplement bias is clear. In their complaint, CSPI makes this outrageous (and demonstrably untrue) statement:

State and federal dietary guidelines and nutrition science experts all agree that (a) nutrients should be met primarily by consuming foods; (b) most Americans are not vitamin deficient, and they consume adequate amounts of vitamins and minerals; and (c) for the most part, only those suffering vitamin or mineral deficiencies (usually due to diet or health issues) benefit from vitamin supplements.

CSPI will attempt to prove, relying on National Institutes of Health and American Heart Association conclusions, that vitamins B6, B12, C, E, and folic acid do not help with heart health—even though studies show the exact opposite is true. They also have to prove that the plaintiffs—consumers—paid a premium for the multivitamin based on “deceptive/misleading” marketing and labeling, and that they were materially damaged in doing so.

As we mentioned earlier, Bayer is also fighting the Federal Trade Commission and the Justice Department regarding claims on their probiotic colon supplement: the FTC is unnecessarily enforcing double random-controlled trial (RCT) standard, despite the fact that Bayer provided hundreds of studies supporting their s/f claims for the product. The Federal Trade Commission Act does not require RCTs for s/f claims. In fact, when it comes to supplements, RCTs are not necessarily the “gold standard”—a topic we explored in depth two years ago.

CSPI seems uninformed about many issues that affect consumer health. In addition to the false belief that nutrient levels are adequate, they support GMO crops—CSPI consistently sides with Monsanto and the GMO industry. CSPI also defends the revolving door policy that led former Monsanto employee Mike Taylor to become head of food safety at the FDA.

Even worse, CSPI asked the FDA to abolish s/f claims and qualified health claims (QHCs). With a QHC, one may ask the FDA for permission to make a minor health claim so long as it includes a qualifying term like “may,” as in “Vitamin D may prevent or treat the flu.” ANH-USA helped establish some important QHCs for saw palmetto, folic acid, omega-3 fatty acids, fiber, vitamin E, vitamin B, and selenium.

If the court rules in favor of CSPI, it could have a chilling effect on s/f claims even though they are completely protected by federal law. We are especially frustrated by the ludicrous claim that “nutrition science experts all agree” that Americans are not vitamin deficient and should get nutrients from food alone. We will keep you posted as the case moves forward.

Share.
  • Most of us LIVE on supplements because our food is produced in such a way as to be not only not nutritious but actually dangerous to eat.

  • Andrew D. Whitmont

    “Scientists agree” that we are not alcohol deficient or mobility deficient. Therefore, we should not be able to sell alcohol or claim that automobiles get us from place to place. After all, there is no need!

  • Quinine (tree bark) controls/prevents malaria. Vitamin C prevents/cures scurvy. Vitamin D prevents ricketts and a whole host of health problems still being discovered. Vitamin K prevents blood cholesterol and blood calcium from bonding, forming plaque, and causing arterial sclerosis. Aspirin (tree bark) reduces inflammation and fever. Vitamin E in medicinal quantities thins the blood better than pharmaceutical drugs, and does it for much, much less cost. The list goes on and on. We need to circulate all the known remedies and put these nay-sayers out of business, or at least out of our business! Back in 1200 AD the local “witch in the woods” was putting moldy bread on wounds to prevent infection. . .

  • Charlotte Braun

    Instead of looking into supplements, Pharmaceuticals should be scrutinized more closely because they are the ones which cause more deaths each year. One drug causes many side effects and then a person has to take another drug. What is wrong is that there is a great deal of money to be made from pharmaceutical drugs and no one wants to end that, even if it is a matter of life and death.
    Leave the supplements alone!!!!!!!!!!!!!!

  • Derek Stanton

    Just who are these folks at CSPI and where to they live? If everyone in this country bought and ate wholesome, organic foods eaten raw or cooked with care, their claim might carry some weight. But just look at the population and the steadily declining rates of health across the board. Where have all these overfed undernourished people come from if all is well at the table? The American diet is a disaster borne of the usual Corruption by Big Money in nearly all phases of the food industry from field to table. Get real CSPI. Supplements cannot possibly compensate for all this damage but where is the dietary harm? Who are these people and what are they up to?

  • MaryLee Hicks

    We know that fruits and vegetables produced on factory farms deplete the soil, and demonstrably contain fewer vitamins that organically grown products. In addition, some of us need more of certain nutrients than others, especially as we age.
    The assertion that most Americans consume a diet adequate in nutrients is preposterous!
    The AMA recommends the use of multivitamins. Please let citizens decide what supplements we need or want.

  • Gary

    As is always the case…follow the money. CPSI is obviously in the pocket of whoever will pay them. It would be wiser for folks reading this here to send comments to the CPSI, rather than simply commenting here. We need to let them know we don’t support their actions and will do our best to get the word out that they can not be trusted.

  • Mac Hayes

    Absence of “vitamin deficiency” is not grounds for restricting public access to the supplements marketplace. Why does CSPI want to prevent the public from buying foods and supplements that won’t hurt them when taken in reasonable amounts, and which may actually help people? The FDA sure seems to be managed by control freaks.

    • Mac Hayes

      Add to my comment: How can CSPI possibly back up the claim that ” only those suffering vitamin or mineral deficiencies … benefit from vitamin supplements”?

  • Absurd and harmful.

  • Robert Cruder

    Wild claims assume us to be ignorant as do meaningless buzz-words invented by marketeers.

    Offering dosages well below those used by researchers in order to avoid liability, reduce cost or merely to allow dozens of trendy ingredients to be included cannot provide the research results touted for any one ingredient. A combination does always risk more side effects. Proprietary combinations invite the FDA or the FTC to intervene.

    Those who condemn multi-million dollar studies funded by Pharma have no problem with cheap, small non-repeatable and often unpublished studies funded by a single provider of a raw supplement ingredient. The research on green coffee extract was bogus and even if it were not bogus the public was gouged for tiny dosages. Everyone from garage bottlers to Dr. Oz touted it while consumers wasted money and observers rooted for government intervention.

    Some of us prefer that the FDA/FTC ban label and brochure claims while the FDA/DEA would stops banning substances. Research it, use it and judge by results without either the cost or the placebo effect of vendor advertising.

    • Bruce Stewart

      Yes, I really liked the multi-million dollar study on Vioxx that gave my mother-in-law a heart attack or the multi-million dollar study on thalidomide that caused so many birth defects and the list goes on and on…….

      Some supplements may be worthless but that’s for me to decide after I’ve done my own due diligence. I’m not aware of a supplement that causes the harm of even some of the most benign prescription meds.

  • Bev Bryson

    I am glad this is under review. All kinds of products that are untested are distributed through marketing material, to people all over the world. Some are harmless, others are not so benign. I see countless adds for supplements championing we need to take this and take that, solely based on anecdotal evidence (read opinion rather than fact). Complicating the issue is the lack of testing of these products for contamination and adverse affects, including interactions with other supplements and medications. I for one think that supplement stores should be called just that – supplement stores. The term health food and natural foods should be severely restricted to only organic whole foods – fruits and vegetables -period. The local market is your best source for super foods.

    • Deb M.

      If you hadn’t noticed, the organic produce section of every single store in America is so small as to hardly be in existence. Our food has very little nutrition in it compared to 100 years ago, and it’s even worse for conventional produce. I agree that some supplements are below par (mostly those found at Wally-world and the like), but whole-food supplements aren’t included. If any restrictions are made, they should be made against the vitamins that are mostly made synthetically and which contain fillers and fake sweeteners like aspartame.

  • Dr. Robert H. Fletcher (MD, MSc) and Dr. Kathleen M. Fairfield (MD, DrPH) reviewed all English language papers published on vitamins and the prevention of occlusive coronary artery disease and other conditions. They concluded that, “recent evidence has shown that suboptimal levels of vitamins, even well above those causing deficiency syndromes, are associated with increased risk of chronic diseases including cardiovascular disease, cancer and osteoporosis . . . a large proportion of the general population has less-than-optimal intakes of a number of vitamins, exposing them to increased disease risk . . . it appears prudent for all adults to take vitamin supplements . . . multivitamins, rather than individual vitamins, because multivitamins are simpler to take and cheaper than the individual vitamins taken separately and because a large proportion of the population needs supplements of more than one vitamin.”

    Dr. Fletcher is Professor Emeritus of Ambulatory Care and Prevention at Harvard Pilgrim Healthcare. He has 187 published papers. Dr. Fairfield is Faculty Physician at the Internal Medicine Clinic within the Maine Medical Center and is a CORE Clinician Investigator.

    References:

    Fairfield KM & Fletcher RH. Vitamins for chronic disease prevention in adults: scientific review. JAMA 2002; 287:3116-3126.

    Fletcher RH & Fairfield KM. Vitamins for chronic disease prevention in adults: clinical applications. JAMA 2002; 287:3127-3129.

    • Bev Bryson

      It is true that most adults in North America are probably vitamin deficient – grossly overfed with junk food and underfeed nutritional food. Using research to justify consumption by the masses of supplements does not mean that the deficiency will be corrected. Bodies are made to consume and utilize whole foods and whole foods are made to be eaten that way. Taking one component in pill form doesn’t mean it will be assimilated by the body for benefit. We saw thus with Vitamin E. HUndreds of thousands of people were told to take Vitamin E to protect them from heart disease (which it does). However, it turned out years later when the studies were done, the reverse was the case. People getting adequate vitamin E from whole foods were in fact protected. Not only did the supplement group not benefit, their risk of heart disease actually was made worse. An apple a day keeps the doctor away. Apples are made up of at least 450 different substances. No supplement that takes one or even a few compounds and puts them in a capsule can ever replicate what nature gives us.

  • Suzanne

    Again, talk to nutritionists and NDs who have seen, over and over how supplements work for their clients. They shouldn’t listen to organizations who are anti-supplements.

  • Once again, the organization which has earned the title of the Center for Science in Their Own Interest has shown their ignorance. They demonized coconut oil and butter years ago and refused to even respond to Dr. Enigs letters loaded with proof that they were wrong. Too bad so many people feel that they are respectable and honest as it hurts us all since neither is true

  • i am sure you are well intended, but many doctors, mainstream doctors depend on vitamins as part of a patients treatment plan. I have the right as a consumer to decide what treatment I seek. all you have to do is research any given drug to find how it impacts a patients health, both positive and negative. the negative is usually in the form of depleting various vitamins. Given the amount of drugs Americans take it is not much of a stretch to know many of those patients are vitamin deficient, from doing nothing else but taking a legal drug.

    Please rethink this lawsuit, it will further hurt American health.

    Rosetta Johnston

  • barbara kepley

    Drugs kill herbs and vitamins heal. Very simple but greed also kills.

  • and that is why Americans are more healthy than citizens from any other country! Too bad though, that that is not true!!

  • SHW

    The FTC infuriates me more than the FDA. Why? Because they got Congress to create themselves a job; without any monitoring from Congress. The first step, was to focus on targeting our children on Saturday morning TV for sales of sugary cereals with treats to lure them to buy and eat expensive nutrition-less breakfasts and snack food. And then, busted cereal companies for making claims and label violations. It is a billion dollar industry. Every food supplement company is targeted and monitored that is making any money. Again, the FTC and the FDA or absolutely ignorant of what and how food and supplements produce health in the body. Probiotic is their money tickets. When the FDA and the FTC took down Dannon Yogurt Company for making “immunity claims” for their product Activa; the end result pissed off Russia the world leader in Probiotic Research and sales that they made a special trip to America to train the FDA. Activia was an inexpensive pretty good yogurt that I could send people to the grocery store for a reasonable price that changed their digestive health for the better, and especially Seniors with clogged bowels from daily pharmaceutical medication. Ultimately, killing them. After the bust from the FDA and FTC then the Attorney General steps in and files a class action lawsuit with a pay back agreement. Why don’t they do this for oxicoten killing junior high kids? And, toxic chemo therapy.

  • PEG

    I am 90 years old and have never taken poisoned meds doctors have suggested. Instead I take supplements and Dr says I have excellent health. I think due to not using drugs but just the natural way. I will continue as I am. PEG WRIGHT

  • Neal Ali

    Who are these CSPI people?? Are these Government employees, paid with my tax dollars trying to feed me misinformation about products that I have been using for more than 70 years and know first hand that they help me stay healthy??
    OR are they a “bought and paid for” organization for some major benefactor who will profit from all supplements being banned??
    I would have to say that they are either very, poorly educated and misinformed on the food products sold and eaten in this country, ‘OR’, they just choose to ignore the many published scientific papers on supplements. and the many doctors trying to raise aware of what we should eat and supplements to take.
    We have huge quantities of food products, but QUALITY is lacking..They need to read more on the health status of especially the younger generation. It would be interesting to know whether these CSPI people have families and the health status of their children.

  • Don Van Ostenberg

    Who supports CSPI? Follow the money. Their claim is total nonsense.

  • Jan

    I cancelled my subscription to CSPI’s newsletter in 1981 because of their promotion of vegetable oils. I had written a letter to their nutritionist at the time about this but never got a response. Since then, I’ve often wondered if they were a front group for NIH or some corporate entity. This seems to support that theory.

  • Glenis Batley

    This suit is absurd. If you lose you don’t deserve to exist. I would think that everyone in the alternative health community would contribute to this action. If you can’t present a zillion pertinent refutations, you’re working for the other side. So do well!

  • fallingman

    The Center For Science in The Public Interest is the same group that pushed for so hard for so many decades to get rid of fat in the diet, buying the fraudulent Ancel Keyes hypothesis hook, line, and sinker.

    Now how well did that stance serve the public interest. How many people got chronic illness as a results? tens of millions? These people are self-righteous, meddling know-it-alls who in fact know NOTHING. They KILL people.

  • Richard Bruno

    How much of our tax money are these morons (CSPI) getting? Whose paying for this BS?

  • If our food is packed so full of nutrients, Why are millions of Americans sick and dying.

  • In all fairness if we were to remove supplements that people do not need then we should remove prescription drugs that are not needed and often dangerous.

  • Bob Ford

    To the Center for Science in the Public Interest:

    When did you switch from pursuing science that was in the public interest to pursuing dubious science on behalf of corporate interests? Yes, I know, Bayer in this case is a large corporation. However, in this case you are representing the multi-trillion dollar medical industry, which has been trying for years to either eliminate or take over the health food/dietary supplement industry.
    If any integrity remains within your organization, we should soon be seeing a change n the name to “Science in the Special Interest” or some such.

    • Bob, as Ken Marx states above, the CSPI are a self appointed bunch of nutritional pseudo science busybodies who, in this particular instance, are promoting something odious enough to use Bayer’s court precedence to combat them. Sometimes the enemy of my enemy is my friend.

      Obviously Bayer’s One-a-Day vitamins are chemical rubbish, but that is not presently what is at issue. If the CSPI petty tyrant authoritarians defeat Bayer, the entire supplement industry will fall prey to Draconian regulation. ANH-USA has not gone off the reservation. They are fighting the good fight.

    • David Gaffaney

      Your special interests I believe are self interests. Please leave my freedoms alone..

  • Center for Science in the Public Interest sounds so civic minded, like an organization that really cares about the people. Ten or 15 years ago, they could get away with such nonsense, but today people are waking up and realizing they’ve lost a lot of their liberties. We don’t want to lose anymore and we want some back that have been lost. CPSI, like all liberal organizations, cannot win in the arena of ideas and therefore turns to the legal system to coerce society into doing what CPSI wants. Let’s hope the judges are wise enough to reject their advances.

    • David Gaffaney

      Please keep your hands off my freedom to choose what supplements I wish to take.

  • Sharon

    So, so sick of “groups” trying to keep us sick and dependent on the “medical” industry. Time to start another petition to stand against groups such as this.

  • Darlene Murphy

    This lawsuit is complete and total hypocrisy! You have no right to take supplements away from any of us. You think I get the proper amount of nutrition from the crap that I eat? Really? Well, come live on my salary and then tell me you think I’m fine without supplements!!!!

  • brad roon

    Let’s step back and get some big picture clarification. If one does not have vitamins and minerals they are GOING to die or develop diseases based upon nutritional deficiencies. Period. The root to the word “vitamin” is based upon the premise that if you have no (example) vitamin C you will go through many symptoms and die. The same hold pretty much true for all the vitamins.

    So real science proves that these vitamins and nutrients ARE NECESSARY no matter what any industry or social engineering front group wants to pretend. We now have to choose whether we are going to follow the precautionary principle for once and allow people the option of being healthy, or whether we are going to let the food NAZI’z win and steal this freedom too.

    Legally? The US Fed Govt has ZERO authority over our health choices. There is a difference btwn legality and lawful. By law the Constitution states that the fed govt has 30 specific areas of power which they can deal with, and these are called the ennumerated powers. Health choices and restrictions, food restrictions and choices do NOT number among them. The Constitution further states that ALL rights that are NOT specifically given to the fed govt ARE RETAINED BY THE STATES AND THE PEOPLE. Since health is NOT an allowable federal power, their laws are legal but unlawful regarding these issues – and the right to make choices remains with we the people. Period. In Calif – our state constitution also does not allow the state to dictate my health or nutrition choices. Period. Again – legality vs lawful.

    So these people are saying that we don’t need the vitamins and supplements when we know that deficiencies cause health problems. We know that from about WWII until mid-70s the calcium content of factory farmed soils was depleted by 75%. From the mid-70s until 2000 the remaining depletion of calcium was a further 75%. This proves mineral depletion. As a chelating agent, ANY Roundup crop (crap) is guaranteed to have nutritional deficiencies in addition to unknown and possibly dangerous proteins never before seen. We KNOW this. And these morons state that we don’t need to supplement? Much of what a vitamin does is to place minerals in the correct biochemical slots and pathways – so to state the mineral/vitamin complexity is not related is beyond reality.

    CSPI is obviously a trade/political food NAZI.

  • What is Big Pharma afraid of? That Perhaps if people take the vitamins and supplements, they will not need drugs that are supposed to “cure” everything? Look at the ads on TV. Every pharmaceutical product they advertise has a list of “possible” negative reactions….When I see the lists, I wonder, “How could anyone even think of taking such a product”…AND how could any physician think of prescribing such garbage?
    How many suicides are caused by drugs that are supposed to relieve depression? I guess the doctor and/or the pharma company can say, “Well, we warned them.”

    Keep taking your vitamins and minerals, folks!!

  • Beckie

    Yeah, the vitamins produced by big pharma have no benefit.

  • http://en.wikipedia.org/wiki/Sheila_Rabb_Weidenfeld It’s the same story over and over—The Pilgrims Society is back of pharmaceuticals, vaccines, genetically modified crops, hospitals seizing children from parents, and 97% of everything else that intentionally harms the public. This Sheila R.W., a director of the Center for Science in the Public Interest, had as her father, Maxwell M. Rabb (Pilgrims Society—see Who’s Who in America in libraries) who was a director of Rite-Aid Corporation, owner of a drug store chain. Rabb was a UNESCO official before becoming Ambassador to Italy for 8 years. He was a top Wall Street lawyer. If I review connections of the other directors, I’ll find more of the same. The Pilgrims Society was the brainchild of South African diamond organizer Cecil Rhodes and it united the looters of the centuries old worldwide British Empire (including the opium business in China) with the “robber barons” of the 1800’s, plus old-line families who received major Dutch and British land grants back in colonial times. This organization still refuses to post any roster to public view http://www.pilgrimsociety.org An organization has a right to privacy, except in this case, privacy equals “secrecy” because so many Ambassadors, Attorney Generals, Senators, Governors, Generals, Admirals, Presidents, Secretaries of State, Treasury, Defense, and Supreme Court justices have surfaced as members therefore—the public has a right to know.

  • Very Simple:

    If the CSPI wants to hold those that are accountable to claims, they believe are unsupported. Then they too should be held equally accountable as well as liable for false and disparaging accusations.

    1. ” most Americans are not vitamin deficient, and they consume adequate amounts of vitamins and minerals ”

    False: Most U.S. adults don’t meet their recommended daily levels of 10 essential nutrients. DOI: 10.1111/jhn.12274 Nutrient intake among US adults with disabilities

    2. ” for the most part, only those suffering vitamin or mineral deficiencies (usually due to diet or health issues) “”benefit from vitamin supplements.””

    TRUE: Well Considering the most Americans are deficient ( refer back to #1) , than I guess logic would dictate most will benefit.

    So, in closing the CSPI’s only lynch pin once rebuked. Should be legally forced to admit to fabrication of (non footnoted ) data, and publicly admit ” That yes it is possible we all can benefit from a few extra nutrients a day…

    That after all would truly be science acting in the public interest… 😉

  • Don Salsburg

    Im glad to see any judgement go against the Bayer Company. I hope they loose. They are a truly evil corporation with at least a 70 year history of horror. This includes producing the poison gas for the gas chambers in the concentration camps in Nazi Germany. To hell with them. I’m quite disappointed that you would support them for any reason and will unsubscribe from your email as a result.

  • Craig

    Why does anyone need an assault supplement?

  • Craig

    “they support GMO crops – CSPI consistently sides with Monsanto and the GMO industry.”

    Nothing more needs to be said.